CSL Behring has received FDA orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The designation was granted for the treatment and prophylaxis of bleeding episodes in ...
Tags: CSL Behring, rIX-FP, hemophilia B
Inspiration Biopharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of IB1001, used for the treatment and prevention of bleeding in individuals with hemophilia B. ...
Tags: FDA, IB1001, intravenous recombinant factor IX protein
Verinata Health has introduced a non-invasive prenatal test to detect autosomal and fetal sex chromosome aneuploidies for high-risk pregnancies. The expanded indication of verifi prenatal blood test detects Turner syndrome(Monosomy ...
Tags: Verinata Health, non-invasive prenatal test, high-risk pregnancies
Baxter International has gained approval for ADVATE [Recombinant Human Coagulation Factor VIII for injection] to treat hemophilia A in China. ADVATE is infused directly into the bloodstream, allowing the body's blood clotting process to ...
Tags: Baxter International, ADVATE, hemophilia A, bleeding episodes
Baxter International has collaborated with Chatham Therapeutics for the development and commercialization of factor IX hemophilia B gene therapy treatment. According to the agreement, the companies will investigate the next generation of ...
Tags: IX hemophilia B gene therapy, Biological Nano Particles, clinical trials
The Kedrion Group, a developer of plasma derived products, has purchased Ortho-Clinical Diagnostics' Rho(D) immune globulin (Human) RhoGAM and Rho(D) Immune Globulin (Human) MICRhoGAM ultra-filtered Plus products, used for the prevention of ...
Tags: plasma derived products, Immune Globulin, ultra-filtered Plus products
Baxter International has received the US Food and Drug Administration (FDA) approval for its 4000 IU dosage strength of Advate[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. Advate is a full-length recombinant factor ...
Tags: FDA, Baxter hemophilia drug, dosage strength